Ceritinib (Oral route)
Tyrosine Kinase Inhibitor
Uses of This Medicine:
Ceritinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer that is caused by a defect in a gene called anaplastic lymphoma kinase. It is used in patients who have already received crizotinib, but their condition got worse or the medicine was not tolerated. Ceritinib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ceritinib in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of ceritinib in the geriatric population have not been performed, no geriatric-specific problems have been documented to date.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
- Brentuximab Vedotin
- Doxorubicin Hydrochloride Liposome
- Eslicarbazepine Acetate
- Ethinyl Estradiol
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bradycardia (slow heartbeat) or
- Congenital long QT syndrome (heart rhythm problem) or
- Congestive heart failure or
- Electrolyte or mineral imbalance or
- QT prolongation (abnormal heart rhythm) Use with caution. May cause side effects to become worse.
- Diabetes or
- Hyperglycemia (high blood sugar) Use with caution. May make these conditions worse.
- Liver disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Swallow the capsule whole. Do not crush, break, chew, or open it.
Take this medicine on an empty stomach, at least 2 hours before or after a meal.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For treatment of non-small cell lung cancer:
- Adults 750 milligrams (mg) once a day.
- Children Use and dose must be determined by your doctor.
- For treatment of non-small cell lung cancer:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If it has been more than 12 hours since your regularly scheduled dose, skip the missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during therapy and for at least 2 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. Check with your doctor right away if you have a cough with or without mucous, shortness of breath, troubled breathing, or a fever.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Pancreatitis may occur while you are using this medicine. Check with your doctor if you have sudden and severe stomach pain, nausea, vomiting, fever, or lightheadedness.
Do not use grapefruit products while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- Abdominal or stomach pain or tenderness
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- clay colored stools
- dark urine
- decreased appetite
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- nausea and vomiting
- skin rash or itching
- swelling of the feet or lower legs
- troubled breathing
- unexplained weight loss
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
- Less common
- Chest pain
- general feeling of discomfort or illness
- irregular heartbeat, recurrent
- thickening of bronchial secretions
- More common
- Blurred vision or other changes in vision
- decreased appetite
- difficulty having a bowel movement (stool)
- pain or discomfort in the chest, upper stomach, or throat
- seeing flashes or sparks of light
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016